SA517381207B1 - Control system for control of distribution of medication - Google Patents

Abstract

A system of controlling distribution of a medication in the treatment or prevention of epilepsy is provided (Fig. 6). A central controller (10) of the system has a data store and one or more processors for reading and writing data to the data store. The data store comprises a database (22) of patient records, each patient record having a medication authorization field. The central controller (10) can output an authorization of a first prescription of epilepsy medication to a patient in dependence upon genetic test results for the patient and schedules a subsequent test for the patient prior to authorization of a subsequent prescription of epilepsy medication. Also provided are methods in which the subject systems find use. The systems and methods find use in the treatment of severe subtypes of epilepsy or refractory epilepsy, such as Dravet Syndrome.

Description

CONTROL SYSTEM FOR CONTROL OF DISTRIBUTION OF MEDICATION FULL DESCRIPTION BACKGROUND Epilepsy is a brain disorder characterized by recurrent seizures. There are causes of epilepsy that include, but are not limited to, cbirth trauma, perinatal infection, canoxia, infectious diseases, ingestion of toxins, 5 cumours of brain. Inherited disorders or degenerative diseases, head injury or trauma, cirauma, metabolic disorders, cerebrovascular accident, abstinence from alcohol. A large number of subtypes of epilepsy have been distinguished. Look; For example Meritt's Neurology 0 (v12). Those skilled in the art will recognize that different subtypes of epilepsy are triggered by different triggers; They are controlled by different biological pathways and have different causes, whether genetic or environmental. A skilled addressee will also be aware that subtypes of epilepsy differ in severity. An example of a severe subtype of epilepsy is Dravet syndrome Dravet syndrome is a rare and catastrophic form of intractable epilepsy that begins in childhood. In hall the patient experiences prolonged seizures 010100860. In their second year; fas additional types of nucleoli occur and this bale coincides with developmental decline; Possibly due to repeated cerebral hypoxia, this leads to poor development of language and motor skills. Children with Dravet syndrome are more likely to experience multiple nuclei on day 0 per day. Epileptic seizures are more likely to cause death in those with Dravet syndrome; Approximately 10 to 715 patients diagnosed with Dravet syndrome die in childhood; Specifically at the age of two and four years. In addition, patients are in

risk of several comorbid conditions including orthopedic developmental problems; Poor growth (failed growth) and chronic infections. Lag is of particular concern; that children with Dravet syndrome are particularly prone to epileptic seizures (dla). epilepicus. The acute and intractable condition is classified as a medical emergency requiring immediate medical intervention; Bale includes treatment in the hospital. Status epilepticus can be fatal. It may also be associated with cerebral hypoxia, which may lead to brain tissue damage. It is clear that frequent hospitalization of children with Dravet syndrome is painful; Not only for the patient but also for the family and caregivers. In addition to Dravet syndrome, there are several other subtypes of epilepsy of comparative severity 0 that are characterized by epileptic episodes of Alla. While there are national or regional differences in the systems by which patients are diagnosed and treated; in general; A patient with Ala symptoms will first be seen by their local doctor (or local hospital or clinic; in the case of severe and severe symptoms). Usually then the diagnosis is made (after referral to a specialist) and the prescription is written by the attending physician. You will take Prescription 5 to the pharmacist who will then supply the prescribed medication. For chronic cases; Repeating prescriptions by the doctor (not always a specialist) and dispensing them from the pharmacy will be provided in the same way. While these regimens may be sufficient and work effectively to treat many common conditions; There are still many potentially problematic situations that may arise and cause a patient to receive their medication delayed and/or incorrect medication supplied. For example; The patient may be misdiagnosed at the start of treatment. alternatively; Even if the diagnosis is correct; Errors in transcribing this diagnosis into patient notes or incorrect or illegible writing of prescriptions by the physician may occur. Moreover; There may be a shortage in the pharmacy, and this means that the cashier must either go to an alternative pharmacy or return to the pharmacy at a later time. Once you restock your pharmacy supplies. For epilepsy patients; Especially those who suffer from severe epilepsy, any delay or error may lead to disastrous results. So there is a need for a system to ensure processing

Epilepsy patients in a reliable and effective way. Until now; The inventors believe that no systems have been developed to treat epilepsy. From dal other » examples of regimens for managing the treatment of other conditions have been developed. For example; The Xyrem success program may be referred to as Xyrem (sodium oxybate) used in the treatment of narcolepsy The drug was used recreationally by itself or as a "date rape" drug, therefore; one of the goals of the Xyrem success program is Prohibition of obtaining xyrem in a form other than aN. Details of this regimen can be found at www.xyrem.com/patient-success-program. 779717 and 4 7895059 8263650 5 8457988 4 4859182 8731963 provides a process diagram outlining the major steps of the Thalidomide program shown in Figure 1. There are a number of problems with this program that make it unsuitable for use in prescribing epilepsy. The program is open to all clinicians, regardless of their experience in treating and diagnosing the condition, provided they are registered.While this is not a problem for a condition with less severe symptoms,5 this approach has been determined to be inappropriate for the treatment of epilepsy, particularly severe subtypes of epilepsy. (Lal) The system relies heavily on faxes between pharmacists the doctor; This is problematic. Sie If faxes are sent to the wrong number If the faxes are not read; If there is any delay in the faxes sent by the doctor or pharmacist; etc. Moreover; Several time-consuming steps must be taken between the patient being diagnosed with the condition in question and the drug being delivered. Additional example of a patient management system in Risk Evaluation and Mitigation Strategies (82245)_thalidomide. Thalidomide is indicated for the treatment of newly diagnosed multiple myeloma and moderate to severe erythema nodosum leprosum. Details of this system can be found in 5 - Hama. [http://www Various aspects of the system have also been disclosed in US Patent Nos. 6045501 6315720 6561976 561977 6755784

6869399 6908432 7141018 7874984 7959566 6204763 8315886 8589188 5 8626531 A diagram outlining the main steps of the program is provided in Figure 2. There are several aspects of this program that make it inappropriate for use in prescribing epilepsy. First, the program is open to all physicians. Regardless of their expertise in treating and diagnosing the condition in question, provided they are registered.In addition, any pharmacy may register to become accredited and thus prescribe thalidomide.This may be a problem as different pharmacies may store and handle data in different ways.Therefore, while any These regimens are intended to be appropriate for the cases concerned by regulatory authorities; it was found by the inventor that they may not necessarily be appropriate for the management of epilepsy patients, given the specific problems associated with epilepsy and related care.The formulations and preparation of fenfluramine using the regimens and methods in question include those described in a publication Universal Patent No. 177676/2014 Any suitable methods for the treatment of epilepsy may be performed in combination with one or more of the Sle methods and systems (as described herein); Including but not limited to; These 5 methods are described in International Patent Publication No. 177676/2014; Its disclosure is included here for reference in its entirety. GENERAL DESCRIPTION OF THE INVENTION Aspects of the present disclosure include a system for controlling the dispensing of a drug for the treatment or prevention of epilepsy. The system can include a central controller with a data store and one or more processors to read and write data to the data store; The data store includes a database of patient records.” Each breeder record has a “medication authorization field” where the central controller can authorize a first prescription of epilepsy medication for a patient based on the results of the patient’s genetic examination and schedule one or more subsequent examinations for the patient before authorizing a subsequent prescription one or more epilepsy medicines.

Detection systems and methods (Jal) can be particularly useful in the treatment of epilepsy; As severe subtypes of epilepsy and/or Mie crefractory epilepsy (gall) Dravet syndrome; and/or to control drugs with associated side effects. The central controller may authorize the first or additional prescription that includes any combination of the following Specific or active ingredient: dose; volume; number; diet; concentration and/or time periods intended for use by the patient. A central controller may issue a license in the absence of results of a patient's genetic examination; incomplete and/or incompatible data formats. The central controller may instruct and/or coordinate the genetic examination of the patient and/or one or more subsequent examinations of the patient.This centralized management of the specific examination to be performed is particularly useful and can allow the central controller to detect any combination of: Type 0 examination;Examination conditions/criteria and/or the format of the test results. In addition or alternatively, the central controller may control/authorize one or more teams to perform the test. This central controller is not to authorize the recipe chad but load performs the checks to determine anal suitability In contrast to the previous domain, however, it has been determined that it is particularly useful for control By distributing the drug as the side effects of the drug can have significant health effects on the patient. This centralized control 5 Lad may reduce or prevent misdiagnoses of one or more epileptic conditions. This has been found to be critical for drugs that have the potential to cause physiologic deterioration of one or more organs over extended periods of time. In the example of the central controller describing the data formats for the scan results; The data format can be associated with patient examination data fields and/or the database format for patient records. This (Sa 0) could allow a hitherto unavailable degree of automation (AV) and/or control over medication distribution to patients. In one example, the central controller and/or data store might include a dad check data threshold A central controller or data store may include one or more computer models or algorithms to determine whether or not to authorize a 5-drug prescription and/or the prescription dose/diet.The central controller can input test results for a single patient or more over time to generate a chart or trend in one or more scan data fields

The central controller predicts future examination outcomes, one or more drug use approaches, and/or can compile patient examination data as a reference to one or more predefined models. This method of control is very useful in allowing the patient to determine potential treatment outcomes; 5. For example, to be able to modify or discontinue an existing prescription if it is determined to be ineffective or potentially harmful to the patient. In addition or instead of that; These methods could allow the control system to learn patients' patterns or responses to a drug; So that the control system itself can be developed with use. These features are useful in allowing the development of an existing program of care; prescription authorization process and/or so that a central database can serve as a knowledge base. Given the above benefits. systems can; Methods and/or the central database serve 0 as a research tool to develop an understanding of one or more lie and/or manage a companionship program. In addition, the collection of information of the type described herein is within a central database; Restricted access Allows the export of relevant data to the necessary authorities; including regulatory authorities such as the Food and Drug Administration; the European Medicines Agency; Medicines and Healthcare Products Regulatory Agency; or similar organisations. The controller can allow statistics to be reported; directions or outcomes for the care programme; For example regulators and/or research partners or other organisations. Maintenance of these records can thus be centralized; (Sle) is a prescribed formula; an important feature in the implementation of the invention. According to various examples from the present disclosure, the post-test may differ from the genetic test. The post-screening may include a physiological test and/or a genetic test. The central controller can schedule Sle (spontaneously) one or more subsequent examinations of the patient; 0 For example upon receipt of the results of a clinic examination or upon issuance of a prescription authorization or upon confirmation of delivery/receipt of an authorized prescription to/by the patient. The central controller can schedule a specific time/date and/or period of time by which the post-check should be performed. The timing of the post-Bale check is within a period of time that the authorized prescription is in use. The central controller can issue an initial or subsequent time period within which 5 shall use by the patient is authorized Sle cy after requesting receipt of the results of the patient's subsequent examination before an additional time of use can be authorized for the patient. In one example; Timing will be checked

request a repeat prescription; for example by the patient or the doctor; Against the time period specified by the central controller Sarg can usefully allow monitoring of patient adherence to treatment. The central controller can authorize repeat prescription of the drug depending on the results of the subsequent examination. The central controller can change the prescription and/or authorized time period Until a subsequent examination is requested based on the results of the patient's examination.In one example, a patient record can be created on a database if the results of the genetic examination are available to the patient.The entry of the patient into the database is prohibited by the central controller unless a predefined format is received or Less choice of patient screening data fields by the central controller. This ability to screen patients before any possibility of prescription authorization is useful 0 because it is fail-safe to ensure that a single nurse cannot be issued an unauthorized dub prescription; (lia Human error When combined with a central controller's ability to control initial and/or subsequent patient examinations, this provides a strictly rigorous system for managing patient diagnosis and drug distribution. The control center can authorize prescription and/or dispense co-medication,; or through an affiliate distributor. Can be supplied to the Tash Control Center upon receipt of medication by the patient 5; For example, include the time/date of receipt. Confirmation can include statements referring to or any combination of the following for a specific drug or active ingredient of the prescription being communicated: dose; size; number; diet; concentration and/or time period for use by the patient. Subsequently; The delivered medicine can be checked by the central controller. The central controller can start delivering prescriptions to patients. The 0 database can contain dis 1 or more receipt addresses per patient. Bile receipt may be given to the patient and/or not include the prescribing physician. Subsequently; The central controller can act as a central pharmacy. In addition or instead of that; The central controller can provide a central prescribing authorization controller who instructs associated pharmacies whether or not to supply prescriptions to the end patient. Each associated pharmacy may require confirmation/authorization by the central controller before the distribution of prescriptions in accordance with the invention is permitted.

The subsequent medical examination of the patient may or may not include an examination to change the patient's clinical condition. The post medical examination may include an assessment of the structure and/or function of one or more specific organs. Post-examination may include a visualization of one or more particular members; For example, by means of sonography, echocardiography, or another appropriate technique. One or more particular members may or may not include the core. Test results may or may not include one or more images of the organs as an echocardiogram .all Scan results that include one or more images can be transmitted to the central controller. In addition or instead of that; A lily summary or associated processing/derivative data may be transmitted. The system may include a portable or wearable electronic device to monitor the patient's health. The electronic device may include one or more sensors to measure one or more indicators of the patient's health; like; For example; any combination of blood pressure; call echocardiography electrocardiography “all heart rate heart crate oxygen in oxygen all 51000; temperature; Lung functions p. 100. The electronic device can take readings indicating the functioning of one or more organs, which could be the organ that is the focus of the subsequent examination. The electronic device can be configured to transmit sensor data (a subset, processing group, or data results (ula) to, or to be received by, a central controller. Sensitive results can be treated; lie by electronic device or central controller; so that only certain sensor data inputs or results can be recorded by the controller on the central data store (eg on a pana 0 database) thus continuous, ongoing or intermittent patient monitoring and processed sensor data can be used so that only key indicators can be entered into the store Central data. For example, one or more algorithms may be used to process sensor data and issue an indication of normal or abnormal; or deterioration in patient health laid to a program of care. The results from the electronic device may be used by the central controller to determine/issue 5 Change to the nurse's scheduled medical examination and/or change of prescription authorization or change of medication prescription.

The central data store may include the database of licensed providers; as medical professionals. Licensing a treatment and/or writing a patient description may require that patient input be associated with the physician content within the licensed provider database. This could also allow for control over which doctors are able to prescribe medication. This level may not be used

This is preceded by a measure of control to ensure that only key experts or previously vetted specialists are authorized to prescribe the drug. In a second aspect of the present disclosure a method is provided for controlling the drug's dispensing; As one or more properties in accordance with the system from the first side. A method or system may include a method/system for operating a patient care programme. In a third aspect of the current disclosure; dels provides a data carrier containing readable instructions for controlling one or more processors to act as a central controller

0 in correspondence with either the first or the second side.

where possible; Any of the Essential or Preferred Features identified in conjunction with any aspect of the current disclosure may be applied to any additional aspect. Accordingly; Embodiments of the invention may include various alternative settings for the features identified above. Brief description of the drawings

Embodiments of the invention are described in greater detail below by way of example with reference to the accompanying drawings; in which:

Figure 1 shows a flow chart of the steps involved in a first example of a sponsorship program according to the previous domain;

Figure 2 shows a flow chart of the steps involved in a second example sponsorship program by domain

0 previous;

Figure 3 shows a rendering of a system and network according to the present disclosure;

Figure 4 shows a flow chart of the steps involved in the physician approval process according to an embodiment of the current statement ¢

Figure 5 shows a flow chart of the steps involved in the perch approval process according to an embodiment of the disclosure

5 current; And

Figure 6 shows a flow diagram of the Why drug distribution process for an embodiment from the present disclosure. Detailed Description: As I summarize above; Provides a system and method for centralized control of a program of care and issuance of associated prescriptions. Sponsorship programs in the former focus Bale on managing the risk of the Sponsorship Program. in contrast; The Jal detection embodiments described herein are intended to facilitate a more patient care Vad program which can include both: 1) confirmation of diagnosis; 2) check for call 3) monitor the profile for side effects and/or identify failures in efficacy. Systems in accordance with the previous field are not suitable for the treatment of epilepsy; exactly Certain sala forms of epilepsy. The system described and claimed herein is also suitable for use in the management of patients with other conditions”; Care includes the same concerns

0 or similar in severity of symptoms; patil compliance » side effects and efficacy. The present disclosure provides for a program of care that includes one or more drugs known to adversely affect a patient's life expectancy. Existing systems and methods are appropriate for programs of care where the drug(s) have a cumulative adverse effect on the health of the caretaker over extended periods of time; as months or years. in these circumstances; Careful prescribing and drug distribution can be used to control the balance between drug efficacy and effect

5 negative on other aspects of the patient's health.

Existing systems and methods have been developed for use with specific drugs as described below that have side effects that require greater control than that provided by the prior field. in such cases; It has been found that controlling an initial prescription and/or repeating ongoing prescriptions according to specific patient examinations can significantly improve patient outcomes.

There are a large number of subtypes of epilepsy. Whereas all forms of epilepsy disturb both the patients themselves as well as their parents, their caregivers, and their friends; Some epilepsy subtypes are more severe than others. With “sala” a reference is created for; For example » subtypes of epilepsy that are refractory and/or that are characterized by episodes of status epilepticus. Subtypes of epilepsy include such; But not limited to; Dravet syndrome Lennox-Gastaut syndrome

5 West syndrome, Dowes syndrome, syndrome 10056 and/or other types of refractory epilepsy.

The system described and purported herein is suitable for use in the management of epileptic patients with dallas

using any appropriate drug; if supplied alone; as a preparation or as a combination containing other bioactive drugs Lisi; which are useful in the treatment of epilepsy. in some respects; The drug is a receptor agonist, an antagonist, or an allosteric agonist.

-modulator 5 in certain aspects; Vlad is at one or more calin i (5-HT) 5-hydroxytryptamine subtypes and/or subunits thereof. in some respects; The drug induces neurotransmitter synthesis or Ay "storage neuropeptide" release; decay; recovery and/or activity. On the other hand, the drug is an ion channel blocker in certain aspects; The property is a property that adjusts the balance between transfers

Excitatory and inhibitory neurotransmissions in the brain of a patient with epilepsy. in some respects; A drug is a drug known to be effective for patients with epilepsy who have one or more genetic mutations in certain aspects; The drug is a drug known to be effective for patients with epilepsy who are unresponsive to drugs commonly used to treat epilepsy.

15 in some respects; The system is suitable for use in the management of epileptic patients with “lie” or a drug composition who either directly or indirectly cause; The activity of one or more 5-hydroxytryptamine receptors in the ovarian brain when an effective dose of these compounds or combinations is administered to the said patient. in some embodiments; One or more than one 5-hydroxytryptamine receptor is selected

0 . or more than 1 5-hydroxytryptamine 1,5-hydroxytryptamine (:5-11)» 5-hydroxytryptamine 1 (((5-HTia) S5-hydroxytryptamine 1A 5-hydroxytryptamine [b-5¢(5) -HTip) hydroxytryptamine 1B 5-hydroxytryptamine 1c 16 5-hydroxytryptamine )-5 (HTic 5-hydroxytryptamine “(5-HTip) 5-hydroxytryptamine 1D al 5-hydroxytryptamine 1H ((5) -HTig) S-hydroxytryptamine 1E 5-hydroxytryptamine (sl -5)

5-) 5-hydroxytryptamine 2 2 5-hydroxytryptamine ¢(5-HTir) hydroxytryptamine 18 25 5-hydroxytryptamine ¢(5-HT2a) 5-hydroxytryptamine 2A 2 5-hydroxytryptamine (HT:

Tryptamine 2b 23 (5-Htop) 5-hydroxytryptamine 5-hydroxytryptamine 2g-5¢(5-HTac) hydroxytryptamine 2C 5-hydroxytryptamine 3 3 5-hydroxytryptamine (-5 (HT; 5) 4-Hydroxytryptamine 5-Hydroxytryptamine; 5-Hydroxytryptamine 15 (5-Hydroxytryptamine 5B 5-Hydroxytryptamine 6; 5-Hydroxytryptamine 7 among others 0 In certain embodiments; the drug is a creceptor agonist agonist 2010051 or an allosteric modulator .according to one aspect of the present invention, in which a system is provided for use in the administration of Glas (ane) treatment with epilepsy using a drug preparation or drug combination that induces receptor activity one by one The receptors or all of the foregoing receptors.In some respects the regime declared die herein claimed is suitable for use in the management of the treatment of epileptic patients with “lie a drug preparation or drug combination that is effective in inducing synthesis; storage; release; dissolution; recovery and/or the activity of one or more neurotransmitters or neurotransmitters involved in triggering one or more of the symptoms. Epilepsy or cause its frequency or duration. in particular embodiments of this aspect of the invention; Neurotransmitter 5 can be a transporter of dopamine serotonin Lele (GABA) gamma aminobutyric acid among others 0 in representative embodiments aad; The neurotransmitter Ble is responsible for serotonin. On the AT side of the invention; The system is suitable for use in administering therapies that use drugs that act as ion channel blockers 100. In one embodiment drug 0 is a Cals level sodium channel blocker?. in some respects; The stated regimen aie and herein claimed is appropriate for use in the management of epilepsy patients with lie drug preparations or formulations that are effective in preventing or treating symptoms of epilepsy in patients who have one or more genetic mutations. It can include such mutations but is not limited to mutations included in the beginning; Frequency » severity or duration of epilepsy symptoms 5; Which includes but is not limited to nucleoli. Examples of such mutations include, but are not limited to: Mutations in the sodium voltage-gated alpha channel subunit genes.

(SCN1A) Channel Alpha Subunit 1 (eg partial or total deletion mutations; Mie cut-off and/or missense mutations in voltage regions or poison 54 or voltage-gated Wl subchannel (S6) sodium 1b (as the region that encodes beta subunit 1 of the sodium channel); sodium voltage-gated alpha subchannel 2) sodium voltage-gated alpha subchannel 3) sodium voltage-gated alpha subchannel 9a Lela m-aminobutyric acid gamma-2 receptor subunit (GABRG2) aminobutyric acid type A receptor subunit (such as the region that encodes a gamma-2 (GABRG2) aminobutyric acid type A receptor subunit (GABRD) ) Aminobutyric Acid Type A Receptor Subunit Delta) and/or Protocadherin 19 19 (PCDH19). Hence, according to 0 an additional aspect of the present invention, in which a system suitable for use in administering the treatment of an affected patient is provided With epilepsy that shows a mutation in the coal of some or all of the above genes.

in some respects; The system declared aie herein claimed is appropriate for use in the management of adolescent patients. in certain embodiments; The patient's age is less than 18 years; such as under 15; less than 10 less than 5; Less than 2, less than 18 months, less than 1 year; Less than 6" yell or 5" yell from 1 month to 6 months old. in certain embodiments; Patients are 18 years of age or younger; Jie 5 years old or younger; 10 years old or younger; 5 years old or younger; 2 years old or younger; 15 years old

a month or less; 1 year old or JE 6 months or younger; or from 1 month to 6 months old. in certain aspects; Dosing frequency and amounts will vary according to individual patient needs. Dosage can be twice daily; ag once every two days; four times a week; three times a week; 0 Five times a week » Six times a week » Once a week; Twice a week or once a month. Dosage amounts will vary according to patient variables including but not limited to; peal) weight; sharpness; Frequency and/or nature of symptoms. in certain embodiments; Dosage is used in lower amounts of about 0.8 mg/kg/day» about 0.7 mg/kg/day» about 0.6 mg/kg/day» about 0.5 mg/kg/day» about 5 mg/day kg/day » about 0.4 mg/kg/day » about 0.35 mg/kg/day » about 0.3 mg/kg/day; 5 about 025 mg/kg/day or 0.2 mg/kg/day to about 0.1 mg/kg/day”; about 0.05 mg/kg/day; Or about 0.01 mg/kg/day. in certain embodiments; A dose of a beneficial drug is performed

in an amount of 0.8 mg/kg/day or less” such as 0.7 mg/kg/day or less; 0.6 mg/kg/day or less 0.5 mg/kg/day or less » 0.45 mg/kg/day or less 0.4 mg/kg/day or less » 0.35 mg/kg/day or oJ 0.3 mg/kg/day or less (JH 0.25 mg/kg/day or less 0.2 mg/kg/day or less 0.1 mg/kg/day or less » 0, 05 mg/kg/day or less; or 1 mg/kg/day or less. In additional ils; the dose is administered via a pil by intramuscular injection or Jala veins intravenous or by Any other appropriate means Drugs used in therapies for which the current detection regimens are useful may be administered alone or as a drug preparation in which the drug is combined with inactive ingredients, which may include cdispersants preservatives buffers, dyes or flavoring agents, among others. Drugs can also be administered in combination with other agents that may also be active in epilepsy or have other biological activity. Any suitable drug can benefit from established systems and methods. Research In certain embodiments the system is useful for administering treatments that use one or more drugs the following: absorbed cannabidiol; carbamazepine; clobazam 5 fenfluramine midazolam stiripentol estiripentol topiramate and valproate in certain embodiments; Lid can be chemical derivatives or metabolites of these compounds. in certain embodiments; The drug is conjugated with an antibody or a peptide derived from an antibody that; in some cases; Chal jee cli eg can lead to drug metabolism or other aspects of 0's biological activity. In some examples the drug is a cannabinoid in some cases the cannabinoids are substances similar to the effect of cannabis (fie ccannabimimetic 9-tetrahydrocannabinol (L9-tetrahydrocannabinol) Cannabinoids of interest include, but are not limited to, 5,4-dihydro-2-methyl-4-(4-morpholinylmethyl)-1-(1-naphthalenyl- creonyl)-5 16-pyrrulose 3;2¢i=1 t]quinoline--3-one 4,5-dihydro-2-methyl-4(4-morpholinylmethyl)-[R(+)WINS55, 212] 1-(1-naphthalenyl-carbonyl)-6H-pyrrolo[3,2,1-1,j]Jquinolin-6-one

Cannabidiol 0002510101 is a derivative of it; a metabolite of it or a conjugate of it. In some examples; The drug is a cariamazepine derivative; die metabolite or conjugate thereof. In some examples; The drug “Ble for clamizole” is derived from it; a metabolite or a conjugate thereof. In some (ALY) the drug is a clobazam derivative; an edie metabolite or a conjugate thereof. In some examples; The drug is Ble for midazolam. Fide of it; a metabolite from it or comparable to it. In some examples; The drug is a derivative of stiripentol; a metabolite or a conjugate thereof. In some examples; Ble is for topiramate; derived from it a metabolite or a conjugate thereof. In some examples; Ble is for valproate; Fade from him; a metabolite or a conjugate thereof. In some examples; The drug is an active agent of fenfluramine” as fenfluramine” is derived from it; a metabolite from it or comparable to it. in certain aspects; The drug is a chemical derivative of fenfluramine. in particular examples; The drug is a fenfluramine antibody conjugate in some embodiments “the active agent of fenfluramine is fenfluramine” or a pharmaceutically acceptable salt thereof. in certain embodiments; The active agent of fenfluramine is an analogue of fenfluramine; or a pharmaceutically acceptable salt thereof. Includes 5 fenfluramine analogues of interest; But it is not limited to all of those analogues that are resistant to 17-dealkylation, ie (N-dealkylation) by metabolizing enzymes such as Cytochrome Bjax (4 (CYP2D6) Cytochrome P450 206 2D6 450 cases; analogues have Fenfluramine analogues fenfluramine structures that confer all diluted cytochrome P450 2D6 onto the molecule, while maintaining desired target activity.In certain examples, fenfluramine analogues have structures

0 confers resistance to metabolism by cytochrome P450 206. Aspects of the methods under investigation include treatment and/or prevention of epilepsy in a patient involving administration of an effective dose of the active agent of fenfluramine (Sia) fenfluamine or a pharmaceutically acceptable salt thereof to a bleach. in certain embodiments; The method to prevent and/or improve seizures in a patient diagnosed with epilepsy includes administration of an effective dose of active Jalal (fenfluramine (Sia) fenfluramine) or a pharmaceutically acceptable 5-salt thereof to a patient. In dime examples the active agent of fenfluramine is Ble for fenfluramine. in particular examples; The active agent of fenfluramine is a fenfluramine derivative. in examples

certain; The active agent of fenfluramine is a metabolite of fenfluramine. in particular examples; The active agent of fenfluramine is Ble, a fenfluamine conjugate. in particular examples; The patient suffers from Dravet syndrome.

Aspects of the approaches involved in the treatment and/or prevention of Dravet syndrome in a patient include administration of an effective dose of the active agent of fenfluramine (eg, fenfluramine) or a pharmaceutically acceptable salt thereof to the patient. in certain embodiments; A method involving prevention and/or improvement of nuclei in a patient diagnosed with Dravet syndrome includes administration of an active deja of an active agent of fenfluramine (eg, fenfluramine) or a pharmaceutically acceptable salt thereof to the said patient. in particular examples; The active agent of fenfluramine is fenfluramine. in particular examples; The active agent of fenfluramine is 0 fenfluramine derivative. In cline examples the active agent of fenfluramine is a fenfluramine metabolite in certain examples; The active agent of fenfluramine is Ble from the fenfluramine conjugate. in some embodiments of the method; The patient exhibits one mutation; some or all of the genes selected from the group consisting of voltage-gated alpha subchannel J] sodium voltage-gated alpha subchannel ca] sodium voltage-gated alpha subchannel 2) 5-gated sodium alpha subchannel 3a; Sodium-gated alpha channel 19 (gamma-aminobutyric acid type A subunit Lila receptor 2 gamma-aminobutyric acid type A subunit delta and protocadherin 19<The method involves giving the patient an effective dose of the active agent of fenfluramine Sie) fenfluramine )

or a pharmaceutically acceptable salt thereof. Aspects of the present disclosure include a method for stimulating one or more 5-hydroxytryptamine receptors in a patient's brain by administering an effective dose of the active agent of fenfluramine (Sia) fenfluramine; or a pharmaceutically acceptable salt thereof; to the patient.” One or more 5-hydroxytryptamine receptors are selected from the group consisting of one or more 5-hydroxytryptamine 1 5-hydroxytryptamine dl 5-hydroxytryptamine cl 5-hydroxytryptamine 1g; 5-Hydroxytryptamine al 5-Hydroxytryptamine cal 5-Hydroxytryptamine [and; 5-Hydroxytryptamine 2 5- Syme 5 Tryptamine 2 ; 5-Hydroxytryptamine 2b; 5-Hydroxytryptamine 2g; 5-Hydroxytryptamine 3; 5-Hydroxytryptamine 4; 5-Hydroxytryptamine 5; 5-hydroxy

Tryptamine 05(5-Hydroxytryptamine 5b 5-Hydroxytryptamine 6; 5-Hydroxytryptamine

7. In particular embodiments of the method; The nurse was diagnosed with Dravet syndrome. In certain embodiments of the methods described herein the effective dose is lower from about 0.5 mg/kg/day to about 0.01 mg/kg/day. in certain embodiments; The effective dose is given as one or more doses for oral delivery; injectable transdermal inhaler via the nose via the anus 1m66 via the vagina or via the gastrointestinal tract -parenteral delivery in certain embodiments; One or more dosage forms are liquid formulations. In particular examples of the method; Jalal the active ingredient in fenfluramine is used as a monotherapy in certain conditions; Co-administer the effective dose of active agent 0 fenfluramine (Sg fenfluramine) or a pharmaceutically acceptable salt thereof; With one or more co-therapeutic agents. in certain embodiments; One or more combination agents are chosen from the group consisting of carbamazepine; ethosuximide phosphenytoin (AMAL 0G1M05] lamotrigine levetiracetam clevetiracetam ¢phenobarnitol progabide ctopiramate estiripentol valproic acid valproate cvalproate 5 verapamil cverapamil benzodiazepines (such as clonazepam, diazepam, cethyl loflazepate, lorazepam, and midazolam) or a pharmaceutically acceptable salt thereof. In certain embodiments; the patient is 18 or Less In certain embodiments control is provided centrally by an organization In some cases a development and/or property supply organization In some cases control steps are provided machine-readable code 0 in the form of a program or firmware running on a computer system network under control However, certain control steps can be carried out at least in part by manual intervention in combination with the control program op accordingly; various combinations of manually initiated and/or manually initiated control steps can be imagined.

automatically initiated as it will be understood by a person skilled in the art. Going first to Figure 3 where a dale view of a system is given according to an example of the invention; 5 incorporating a centralized control system 10) a medical facility 12 responsible for patient care and accommodation 14. The examples of the invention described below rely on data communications between compatible devices 5)

as it is; be possible in particular examples of the invention; that the necessary data connections are established via Bal Electronic; For example, portable communication devices; Associated with the patient and/or care provider rather than premises or accommodations. as it is; Although a joint implementation of the invention would comprise various premises 12 and 14; It is not necessary to define the invention.

CCS 10 includes a “16drug storage facility le Bale” secure storage facility with restricted access; (Sag) may permit a central control facility to act as a central pharmacy for one type, or a limited number, of prescription drugs according to the invention. The computer system to operate the central control system may be located jointly with facility 16 or otherwise may be Determine its location remotely but in combination with it; eg through a local network

0 scale or full scale as required. The computer system supporting the central control system 10 includes one or more alg servers 18 to control the sending and receiving of data communications to/from the mainframe system; in some cases via the Internet; lie via TCI/IP 101/17 connections or other suitable wide area network over which the central control system 10 can communicate with 5 patients and/or related medical professionals. The mainframe system additionally includes a data store 20 comprising one non-volatile data storage device or GST on which a patient lily base 22 is maintained. In this case » data store 20 additionally includes a medical professional; For example, a doctor; Database 4 and/or Property Inventory Database 26 for the property storage facility 16. The aggregate data store 0 20 can be located at one location or spread out over several locations as required eg with different databases or sections of it maintained on them at different locations/buildings. The server 18 and data store 20 may be supplied as part of a local area network 28. The central controlling network 28 may include one electronic device 30 or a JST such as a personal computer to allow The interaction of the operator 5 with the central control system. Such electronic devices allow, through one or more convenient interfaces, any combination of data entry; data modification; data browsing/search and/or data output (version); on

For example by directing the transmission of data from the data store to a receiver; A printer or other conventional output device. In some cases, the electronic device for one or more users includes a screen or other conventional display. Sae servers 18 and/or Heal operator 30 can be adapted to access a shared datastore 20.

dads 5 medical facility 12 in some cases on a hospital; surgery center; clinic or similar; One or more doctors are associated with her in order to treat epilepsy. Appropriate physicians may include recognized experts; in some cases lead experts; In the appropriate medical condition or field of treatment.

Test 32 can be submitted to perform one or more medical examinations according to the current disclosure at the medical facility 12) or it can be accessible to it under the control of the central computer system. 0 Allows a communication device 34 associated with the medical facility and/or The expert physician communicates remote data communication with the server 18 for the purpose of the invention.The system additionally includes an electronic communication device for one or more patients 36 such as a personal computer, laptop, mobile phone, tablet computer or similar device by which the patient can send/receive communications With server 18 or communication device 34. The patient device is specifically used to communicate drug delivery communications between the patient and the central control system.In certain instances, it can be assigned functions dedicated to the patient device 36 that deal with delivery and/or reception of prescription to the medical facility device facility device 34 or a local pharmacy to confirm receipt of the prescription by the patient.In some examples, the system also includes a patient monitoring device 20 38 containing one or more sensors to measure one physiological parameter or more indicative of the health of the nurse. in particular examples; The display includes one or more sensors to measure the temperature function; Jie is a heart rate and/or blood pressure sensor. In some cases the patient monitor includes a portable and/or wearable electronic device; For example; has a power source; Able to export readings to Patient Communicator 36 and/or Bile 5 to Server 8 or Medical Facility Equipment 34. For example; wrist strap device or other device integrated with; or shared with; Mobile phone or similar can be done

use it for this purpose; In a similar manner to a conventional health monitoring technology. However; Laundry monitor 38 is configured; in some cases; For automated communication with server 18 either directly or indirectly in order to ensure that the necessary format data is supplied and/or at the necessary times/periods. The Patient Monitor 38 can also be pre-programmed to take and/or collect measurements in a pre-determined format eg over a pre-determined period or according to a pre-determined number of parameters or readings. in certain cases; The patient monitor can only transmit aware data when the mentioned preset parameters have been found. For example, to ensure reads persistence and/or to ensure that a predefined data format is recognizable to server 18. In addition or alternatively; The data sent by the Patient 0 monitor can include a single identifier or SST “by packed master data; metadata; identifying address or similar; In order to indicate the patient record to which the data relates. This could allow an automatic update of the patient 22 database at the central control system upon receipt of appropriate readings or associated/derived data from the patient monitor. An example of how to operate an epilepsy care program using the system described 5 is described below with reference to Figures 4-6. A major requirement for the operation of a care program system is that the physician who suggests a prescription for a patient must first be identifiable and pre-approved on the mainframe system; As shown in Figure 4; Before a request is authorized to either enter a patient into the patient database; Or otherwise prescribing a drug to a patient. Approving a physician to refer patients to the system of care requires 0 - number of checks to satisfy the physician. Such audits could include one or more of the following criteria in the appropriate area of patient care: physician qualifications; number of years of practice; reputation as an expert; Number of published articles and/or approved references. in certain embodiments; It is intended that the approved standards will ensure a high threshold where approval will be available only to key experts in the field; Rather they are available to any qualified physician or professional.

in certain embodiments; Additionally or alternatively, the prescriber under the care program may require approval before the prescriber can be authorized by a master control system. Any one or any combination of the above approval criteria may be applied to a prescriber approval process under a program of care. A prescriber can be approved by receiving references from a predetermined number of one or more approved physicians/references. The Doctor24 database contains details of approved physicians and associated approval criteria; For example by sae domains related to each physician's registered approval criteria. A validated legal status field may also be provided for each physician entry into the Ka4 database. Database24 may include details of physicians awaiting approval; Thus 0 certain consent fields are incomplete or insufficient to allow consent to be authorized. In some cases, the physician database includes a unique identifier for each physician in addition to the physician's name; Contact details and an institution or director of the associated medical business. An approval rating can be created and supplied in an additional domain for each physician in the database 24. Once approved » the physician can refer a patient to the program of care by sending 5 a related request to server 18 that includes certain authorization data fields; include the name of the breeder; Barbadian address details gly Other convenient contact details. The request can include a diagnosis, severity indicator, or associated test results for a disease. The referral request of the remote patient is processed by server 18 as shown in Figure 5. The patient details are recorded in the database of patient 22 remote by the server. Each patient record includes a domain that refers to the referring Physician 0 using an ID corresponding to the entry corresponding to the Physician 24 database. Only when registered with a pre-approved Physician ID can a patient be evaluated for eligibility for treatment under the Program. The process of assessing patient suitability includes analyzing the patient's medical examination results; In some cases it includes genetic testing. Genetic testing is scheduled and performed under the control of a central control system (5) 10) ie by a drug company that controls the distribution of the drug in question. Controlling the ovarian suitability screening process in this way ensures that results can be performed according to defined criteria of compliance and/or that it can

That the examination result data be provided in a predefined format that can be examined by a program running after the patient has been approved; Genetic screening schedule is generated by the central control system py and sent to the patient's doctor; and/or operator. The operator may include one or more employees of the drug company and/or organization examined and approved by the drug company to perform the examination under predetermined conditions. Once approved by recipients, genetic testing is scheduled ping Recording time/date; Thus, the central control system awaits a receipt of the test data. If the genetic test results do not meet the criteria for approval of the patient, a communication is sent to the corresponding physician and/or patient indicating inappropriateness to the program of care. In dane's examples a record of successful/unsuccessful patient referral requests could be maintained for each physician. in particular examples; 0 Genetic screening is necessary in which only patients with specific genetic mutations have the relevant signal. Taking into account the adverse side effects of the drug; in some cases; Such patients should not be treated unless absolutely necessary. dil) to genetic testing; One or more physiologic examinations may be performed under the control of the program of care operator to determine a patient's sensitivity to one or more known side effects of program of care medication5. Such an examination may include images of; and/or a subsequent examination of one or more diseased organs. In malin care for a single acute epilepsy subtype or JST certain medications can cause cardiac regression and accordingly an echocardiogram or examination of the circulatory system may be performed in such cases. If cil results of genetic and/or physiological examination criteria for approval; 0 examination results can be recorded and the patient record can be updated to an approved state for the program of care. information regarding the care program is provided; Possible side effects of the drug to the patient through an appropriate medium include; includes a website; dels data; documents or other traditional means. in certain cases; It is necessary for the patient or the attendant to confirm that he/she has visited; Understand(ed) and accept (accept) the risks associated with the treatment of care program. Patient admission can be recorded by the 5 mainframe computer system on the patient record in the database 22 before entering the prescription distribution and patient monitoring phase from the software as depicted by Figure 6.

in particular examples; The patient's initial drug prescription is determined by the central control system 10 in accordance with the patient data recorded in the database; such as age; Gender » Height/Weight » Medical history and/or examination results. mainframe system issues; Such as for example a 30-person (PC) personal computer or 18-server A prescription label label containing patient data

And the prescription to be applied to one 40-count container or more for the prescription. in some cases; The Lad system issues a document or receipt label containing the receipt address for the prescription. These documents/labels can be printed at the storage facility in order to be applied to the prescription prior to shipment. in particular examples; The patient's initial prescription is packaged, marked and dispatched from the drug storage facility 16 according to the details generated by the central control system. The time and date of sending 0 of the prescription can be recorded on the patient record and the confirmation of receipt field is provided in the patient 22 database. Confirmation of positive receipt of the prescription by patient or medical facility 12 can be supplied to server 18 and recorded in the patient 22 database. This confirmation can be supplied By completing the receipt of a prescription from the Internet; In some cases it requires the recipient to be registered on an online web site or portal given by the server 18. In addition or instead; Each recipe can have up to 5 unique identifiers; The confirmation of receipt is only verified by the unique identifier reconnecting to server 18 by the recipient. The recipient's peremptory acknowledgment and prescription can thus be accommodated. in particular examples; A mobile communication device carried by the courier can provide an interface for peremptory verification of prescription delivery in the manner described above. The time/date of the prescription can be recorded on the patient record along with the duration or time range 0 of an accompanying prescription. The system can then issue the last date that a repeat prescription will be authorized; Band or cas coincide with the initial prescription stop date. Unlike repeating traditional prescriptions; No repeat or additional prescription under care programs is authorized by the central control system unless acceptable additional medical evaluation results are recorded on the patient database 22. Such results can be gained by continuous monitoring of the patient using a patient monitor sent 5 to the patient from Before the central control system and/or an additional medical examination is carried out under the control/instructions of the central control system.

Evaluation results can be communicated with server 18 and processed to determine drug efficacy and/or severity of effects

The culprit experienced by the patient. This data can be used to determine an increase/decrease in the repeat prescription dose; Medication discontinuation» switch to an alternative medication and/or discontinuation of the program of care. This blll can be used additionally or as a DIY to determine the appropriate time period for additional prescription or

The appropriate interval until further medical examination of the patient.

As soon as the timing/date of delivery of the prescription is received; The control system can then schedule

Medical examination in preparation for approval for repeat prescription. The medical examination can be scheduled by the Bly control system at a suitable length of time before the initial prescription expires. For example, with the initial medical examination; Each additional medical examination shall be instructed by and conducted under control; control system

0 central. Communications indicating the proposed time/date and location of the medical examination can be relayed to the appropriate departments/devices; such as physician and/or patient equipment 34; 36 Confirmation or scheduling responses are appropriate in order to confirm or re-arrange the examination.

In some cases, the further medical examination differs from the initial examination and includes examination of a single organ of pathogen or SST such as the heart or cardiovascular function. Accordingly; can include

5 Equipment used for examination on imaging/sonography cequipment such as echocardiography equipment in order to evaluate the structure and function of the heart. results are collected; Die in device 32 or pcs 34; According to a predetermined formula determined by the central control system. The results include one or more digital images of the heart and associated cal measurements such as the dimensions of one or more internal structures of the heart and/or the rate of flow through it.

In cases where test results are read and/or interpreted by a human operator; like a doctor; nurse; specialist nurse practitioner or other trainee medical worker; Examination results (Jie Electrocardiograms (21665); Electrocardiograms; Echocardiograms or other examination results may be sent to a central or local reading center to be read by experts with specialized or additional training or with significant experience; Jie is a physician; medical specialist; intern

5 in a dedicated manner or a local expert doctor. The use of centralized facilities offers consistency advantages; Improved quality and credibility of the assessment.

The results are transmitted to the server18) for storage in the patient database22 along with the actual date/time of the examination. The results can be evaluated manually and/or automatically (automatically) by one or more Gob algorithms or routines dictated by a program on the mainframe system. A predetermined format of the results allows them to be compared with previous examination results in order to assess changes in the patient's health

during care under the programme. Algorithms can include one or more simple thresholds to determine ovarian suitability for continued drug prescriptions; such as phenofolramine. in certain cases; maybe

Algorithms additionally or alternatively process/map the medical examination data over time in order to determine a gradient; A trend or other data characteristic in the results. So; Algorithms can model one or more patient responses to a drug or other aspects of a program

0 Care (Sag) can classify the patient's response to a program of care; eg regarding continuing risk to the patient's health; and/or predict the patient's future health over the course of the programme.

Methods for assessing a patient's response to a program of care are useful in changes of administration to a specific patient's prescription. The program of care also allows for the means to research and continually evolve the program of care in response to the patient's treatment outcomes. This is facilitated by a control method; Where better prediction can be used

For the result of the patient's treatment at each stage repeat the prescription. The specific data format is also highly desirable in this. Data can be compared between patients and statistical evaluation performed on all available variables to continually update and improve understanding of the different HET patient and treatment factors. Cua Centralized control of the care program provides an outcome and knowledge with which algorithms or models of patient response can be improved to the care program.

In the embodiment of sending a patient monitor 38 in addition to or in place of additional medical examination; In some cases the device is worn, used routinely/frequently, or carried by the patient allowing continuous monitoring of one or more indicators of the patient's health. In light of the effect of phenfluamine described above or other epilepsy drugs on the cardiovascular system “788©078807” the patient monitor can monitor the cardiovascular function

function 5 Depending on the specific application of the invention, a patient monitor may be used to monitor the ovarian nuclei and issue an alarm or other alert signal for notification by the caregiver. In this

embodiment The caregiver can manually enter the details of each nucleus observed; eg to patient notes; PC or AT computer for transmission to the central control system. so; The patient monitor can be a stand-alone device that does not communicate with the central control system. Different levels of communication between the patient monitor and a computer/local communication device or the central control system itself may be implemented in other embodiments of the invention. in some embodiments; (Sa) The patient monitor may be used to determine the regularity, duration and/or sas of nuclei that the patient experiences during the course of treatment. In certain embodiments, the ovary monitor may include one or more algorithms to determine the ly nuclei type on sensor readings.In certain embodiments, the patient monitor may be used to check the correct 0/0 administration of medication by the patient.The patient monitor may include a clock/timer and a user interface for entering the time the patient takes medication.Can include The patient monitor contains one or more alarms or other alerts to indicate that medication is approaching or late in accordance with a pre-determined routine or the time taken Mie a pre-medication record In any of these embodiments, the perceived/recorded results can be transmitted from the patient monitor 5 to the central control system in order to evaluate and store them against the patient's record.The results of the device can be processed by the device itself or by the central control system into data characteristics and/or indicative trends of the patient's health or treatment response under the care program.Use of a mobile device can be wearable f Epilepsy monitoring is particularly useful in epileptic nuclei (Ka) which are easily sensitized/diagnosed and a matching alert signal can be sent in real time 0 to any or any combination of the central control system; The patient's doctor and/or other volunteer caregiver. For harmful or long-lasting infestations this alarm signal can be crucial in ensuring that proper care is given in some instances; A patient monitor can be usefully used to monitor adherence. The operating status of the patient monitor itself can also be monitored so that any fault or abnormal action of the device can be communicated to the patient care adie or central control system. if dle is in the device; The central control system can schedule a medical examination for the patient before repeating the prescription. the way it was done

The patient monitor described above can be used in combination with physical examinations in order to provide a more comprehensive ongoing assessment of the patient or it can also be used to reduce the frequency of medical examinations (sale). The process of examining and/or monitoring the patient described above can be repeated for each repeat prescription cycle. so; The use history of each patient's record is incorporated over time allowing the centralized control system to not only avoid the significant patient risks it experienced previously but also to replicate successful prescription regimens to the requirements of each individual patient or even across a broader patient group as well. Each change in prescription can be attached by transmitting information to the patient and/or caregiver/doctor. Whereas with preliminary information » confirmation of delivery or approval may be requested prior to 0 authorization of a new prescription. in certain cases; An additional database may be maintained for documentation related to care. Each element carries an identifier; These identifiers can be recorded in the patient database upon transfer to the patient/physician and/or receiving consent. In combination with central control of patient records and management of malin care; The centralized control system allows for drug stock monitoring in the manner of a central pharmacy. The current inventory of 1 or 5 more drugs used in the care program is kept in the drug inventory database. each time the recipe is authorized by the central control system and sent; Drug inventory database can be updated with prescription details including prescription total/volume; The dispatch date and recipe ID are issued by the control system. The drug inventory database is updated with the contact confirmation received at 0 Prescription Safe Receipt. with that »; The inventory database takes into account all inventory held at the drug storage facility and all prescriptions in transit. On the other hand, a drug inventory database can include a prescription duration record so that the database can be interrogated to determine summary data for effective prescriptions. This can be valuable for ensuring restricted access to the patient database; Where workers can access inventory reports and more to control inventory without having to access sensitive personal or medical patient data. Accordingly, the stock database 26 can be updated by issuing non-sensitive data from the patient database 2 and can own databases

These data have different access restrictions. Updating the inventory database can be at least partially automated eg using conventional technology Jie visual/printed codes or FCC chips that can be scanned/interrogated at various stages of transmission or receipt and/or upon receipt of data communications in accordance with the system described above .

in what embodiments; Data transmitted by any device can be encrypted or otherwise protected using conventional means to ensure data integrity. The patient care program described above and its accompanying control system could include: (i) diagnosis confirmation; (ii) adherence verification; (iii) monitoring of the side-effect profile and identification of failure in efficacy; in a manner not yet proposed in On the other hand, genetic testing and/or medical examinations of the patient are performed by cal, coordinated and controlled

0 by the care program control system “cal” i.e. by the drug company, through which all test results can be set correctly in the care program record and fully used to improve the care of the ovaries 0.

The comprehensive nature of the program of care described above makes the large volumes of situ and program data useful not only in the current effective care of acute forms of epilepsy; like a syndrome

5 draft; but also in providing a long-term record that can serve as a research tool for an epilepsy specialist. This enables key opinion leaders and experts in different regions or countries to gather information and potentially collaborate in improving continuing care. so; While challenges prevailed in developing and maintaining a system in which non-standard information is recorded; It was found that the application of this system can open up a great potential in the development of companion care programmes.

On the other hand; Automating many processes in a centralized control system can improve the effectiveness of drug distribution; For example, by means of which drug packages are provided to the patient by the central pharmacy without the need for the participation of a doctor to prescribe the prescription. Embodiments

Aspects of the current disclosure include a system for controlling drug delivery in the treatment or prevention of epilepsy. in some embodiments; The system includes: A data storage facility that includes a database of records

The patients; Each patient record has a drug authorization field; A central controller having one or more processors associated with a communication network that controls the transmission and delivery of data over the network and which is associated with the data storage facility to read and write data to the data storage facility; Where the central controller across the network issues an authorization for a first prescription of epilepsy medication for a patient based on the results of the patient's genetic examination and schedules one or more follow-up examinations for the patient before authorizing one or more subsequent prescriptions for epilepsy medication.

in certain embodiments; The system also includes a drug storage facility that has at least one epilepsy drug stored in it. in certain embodiments; The system also includes a drug storage facility that has at least one epilepsy drug stored in it; The central controller monitors the drug stock in the 0 drug storage facility and controls the dispatch of drugs from the drug storage facility to complete the first prescription and subsequent prescriptions. in certain embodiments; The system is to control the distribution of drugs in the treatment of refractory epilepsy. in certain embodiments; The central controller authorizes the first or additional prescription that includes at least one of the doses; canal number; the system; The concentration and length of time intended for use by the patient of a specific drug or active compound. in certain embodiments; The central controller gives 5 instructions and/or coordinates the genetic examination of the patient and one or more subsequent examinations of the patient. in certain embodiments; The central controller determines the data format for the test results; The data format is parallel

With patient examination data fields and/or patient records database format. in certain embodiments; The central controller records examination results for one or more patients over time to generate a chart or trend in one or more examination data fields. in certain embodiments; 0 The GO Controller predicts future examination outcomes and/or classifies patient examination data with reference to one or more predefined models. in certain embodiments; One or more follow-up examinations include a physiological examination of one or more organs of the patient. in certain embodiments; Subsequent examination includes echocardiography. in certain embodiments; The central controller issues a subsequent period of time in which the drug is authorized for use by the patient and after which it requires receiving the results of a subsequent examination of the patient before 5 a subsequent period of use is authorized for the patient. in certain embodiments; The central controller authorizes duplication of at least one recipe; Changing the recipe and issuing a suggestion to stop the recipe depending on the results

Subsequent examination. in certain embodiments; The central controller monitors the age monitor to collect data and analyze the data to determine the response for processing; And to determine the state of nuclei and types of nuclei. in certain embodiments; The central controller acts as a central pharmacy for the medication and the patient database contains the details of the patient's receipt address; the central controller monitors the drug delivery confirmation at the receipt address. in certain embodiments; The system also includes a mobile electronic device that is carried or worn by the patient in order to monitor the patient's health; The electronic device includes one sensor or iS for at least one ECG call pressure measurement; heart rate; blood oxygenation; temperature; and lung function. in certain embodiments; The electronic device is arranged to supply the sensor readings in a format that can be processed automatically by the central controller. in certain embodiments; A version of the electronic device is used by the central controller to identify at least one change to a patient's scheduled medical examination and a change to a patient's prescription. in certain embodiments; The central data store includes a database of authorized Lula specialists; The central controller issues a license to one or more medical professionals upon completion of one or more data fields indicative of the medical professional's reputation in the epilepsy field. in certain embodiments; The system is for controlling the distribution of drugs 5 in the treatment of Dravet syndrome.

Aspects of the present disclosure include a method for controlling the dispensing of a drug in the treatment or prevention of epilepsy. in some embodiments; The method includes: maintaining a central data storage facility that includes a database of patient records; Each patient record includes a drug authorization field; A version of a centralized controller associated with a communications network and with a data storage facility. authorization of a first prescription of 0 epilepsy medication to a patient through the telecom network only in response to the results of the patient's genetic testing; Schedule one or more subsequent examinations by the patient's central controller prior to authorizing one or more subsequent prescriptions of epilepsy medication. in certain embodiments; The Lad method involves monitoring the drug's stock before

Central controller of a drug storage facility and control of sending medications to complete prescriptions. Aspects of the Jal disclosure include a data bus containing a temporary non-AN 5 readable storage medium that stores instructions for controlling one or more processors to act as a central controller for epilepsy medication by: Control reading and writing data to a central data storage facility that includes a database of records

sick; Each patient's record includes dis drug authorization; issuance of an authorization by the central controller over a communications network for a first prescription of epilepsy medication to a breeder only in response to the results of a genetic test for that patient who is registered in the patient database; Automatically schedule one or more follow-up exams for a patient before authorizing one or more follow-up prescriptions for epilepsy medication. in certain embodiments; The data carrier also includes monitoring of the drug stock by the central controller in the drug storage facility and control of the dispatch of medication ala prescriptions. Sequence list: nin records the doctor as a prescriber in the Xerium Success Program (XSP) 0 "b" faxes the doctor's registration form to the Xerium Success Program record "z" approves the doctor's registration "d" patient's diagnosis In narcolepsy “U” Fill out the prescription for Xyrem “F” Send the prescription via fax to the pharmacy 5 “Rose” The pharmacy checks the validity of the prescription F “The admissions specialist contacts the patient to review the insurance coverage “I” The pharmacy communicates with the patient to schedule the delivery of Xyrem A “The receipt is Xyrem J The pharmacy contacts the patient when the refill time is approaching 0 to “refill the Xyrem delivered to the patient “a” Previous field “n” The doctor registers as a prescriber in the MRMS program Thalidomide (transient receptor potential (() TRP) Transient receptor potential LPS Diagnosis of Patient 5p Gel Patient in transient receptor potential P Patient counseling on contraception; pregnancy test (for females of reproductive potential)

“Y” Fill out the prescription and send it to the pharmacy “S” - Register the pharmacy to become approved to distribute thalidomide yy Approval of the pharmacy “U” - The pharmacy obtains a confirmation number from the thalidomide manufacturer “T” Provides thalidomide to patient “A” End C Missing acceptance criteria ny Start “oa” Receive physician acceptance data 0 “1” Acceptance criteria met “b1” - Issue accepted physician ID 1g Patient referral data received 1 Patient data accepted? lar Entering patient data and scheduling a genetic examination “1g 5 Are the results of the genetic examination positive?” “g[” Issuing a doctor’s ID or requesting breeder data “lp Issuing a drug refusal 1d Entering the result into the breeder database “j1” . Issuance of care program information to patient lad 0 Verification and entry into patient admission “for [” admission screening results and initial prescription identification “m1” Authorization/entry of prescription and issuance of receipt address and tag “1g” Dispatch of prescription; entry of time/date and prescription ID I Is patient receipt confirmed?

— 4 3 — “P.1 Ja n Should the prescription be repeated?” “15” Should the prescription be modified?

Claims (1)

protection elements 1. A system to control the distribution of fenfluramine or a pharmacologically acceptable salt thereof for the treatment of symptoms of a specific secondary type of epilepsy (cepilepsy). The system includes: a data storage facility that includes a comprehensive database of patient records processing patient details; Each patient record has a medicine validation authorization field 5 to enter a first prescription for fenfluramine, a pharmaceutically acceptable salt of which? A central controller having one or more processors associated with a communication network This central controller is associated with a data storage facility to read and write data on the data storage facility storage facility 0 over the network; A data storage facility all has fenfluramine or a pharmaceutically acceptable salt thereof for storage; Cua The central controller of the system is programmed to monitor the 0:08 drug stock in the drug storage facility and is also programmed to control the dispatch of fenfluramine or a pharmaceutically acceptable salt from it from a storage facility drug storage ¢facility and where the central controller controls the sending and receiving of data to and from the data storage facility via AA and acts as a central drug pharmacy; It confirms the receipt of fenfluramine or a pharmacologically acceptable salt, of which 0 is at the address (anal) of the central controller programmed to output via the network. The first authorization for the first prescription of fenfluramine or a pharmaceutically acceptable salt acceptable salt from it to a specific patient who is already subject to the first echocardiographic imaging test, where the output of the ear is dependent on the results of the first echocardiographic imaging test 5 And where the central controller is also programmed to output over a period of time, you use fenfluramine or a pharmacologically acceptable salt from it by an approved patient and to plan the following echocardiograph imaging images of the patient and these following results of the special test The patient is required to receive it before approval of additional fenfluramine 5 or a pharmaceutically acceptable salt of it for the patient; Lads where the central controller is programmed to perform a dependent effect on the following test results selected from an additional recipe approval; The change in the prescription and the result of the proposal to stop the prescription. 10 2. System According to Clause 1 Cua, the central controller is programmed to accept the prescription-related information related to the dose; the size; coll system » concentration and period of time required for use by the patient of fenfluramine or a pharmaceutically acceptable salt LY thereof; Lady Cua The central controller coordinates the following tests for the patient. 15 3. the system in accordance with claim 2; The central controller is programmed to predict future test results and classify patient test data by referring to a predetermined model. 4 System according to claim 1 0 where the central controller is programmed to describe the data format of the test results for each page (the data format aligned with the test data fields for each patient; also where the central controller is programmed to record the results Testing for each patient over time and to generate a trend chart for each patient 5 - 5. The system is according to protection element 1, where the central controller is programmed to monitor the patient monitoring device to collect data related to the patient's treatment; analyze the collected data; determine a patient's response to treatment; and determining the incidence and type of seizures 5 6. The system according to claim 1; Also includes: a portable electronic device carried or worn by the patient to monitor the patient's health; The electronic device includes a sensor to measure information selected from a selection of blood pressure, electrocardiography (ECG) electrocardiography, heart rate, blood oxygen 0 degrees temperature” and lung function, where the electronic device is equipped to provide the sensor readings in a format compatible with the central controller. 7. Order according to claim 1; Where the output of the electronic device is used by the central controller to determine at least one change to a planned medical test for the patient and a change in the patient's medication prescription; Also, where the central data storage facility includes a database for workers in the accredited medical field; Permission to output the central controller to one or more 0 medical personnel when completing one or more data fields indicating the reputation of the epilepsy medical officer 8. The scheme is according to claim 1 where the designated secondary type of epilepsy is a syndrome .Dravet 5 9. A system for controlling the distribution of a drug to treat symptoms of a specific subtype of epilepsy (cepilepsy) The system includes: a data storage facility that includes a database of patient records including processing of patient details; Each patient record has a medicine validation field authorization field to enter a first prescription for fenfluramine. Fenfluramine is a pharmaceutically acceptable salt Pharmaceutically acceptable salt of it?; A central controller has one or more processors associated with a network ccommunication network This central controller is associated with the data storage facility to read and write data to the data storage facility storage facility over the network; And Where the central controller controls the sending and receiving of data to and from a facility Data storage facility via AA and acts as a central pharmacy for medication; And stresses on Receiving fenfluramine or a pharmaceutically acceptable salt from it 0 at the address (anal) of the central controller programmed to be output via the network, the first permission for the first prescription of fenfluramine or a pharmaceutically acceptable salt from it to a specific patient who is previously subject to an echocardiographic electrocardiographic test The first imaging test, where the output of permission is based on the results of the echocardiographic test imaging test 5 The first is also programmed to plan a next medical test for the patient before allowing the entry of the next prescription for fenfluramine or a pharmaceutically acceptable salt in the medicine authorization field, where the following medical tests are a test Echocardiographic imaging test 0 where the central controller is programmed to output over a period of time using fenfluramine or a pharmacologically acceptable salt from it by an approved patient and accordingly the following test results for the patient are required to be received before approval of fenfluramine additional fenfluramine or a pharmaceutically acceptable salt of the patient's own; 5 where the central controller is programmed to perform a dependent effect on the following test results selected from an additional recipe approval; change in prescription and resulting prescription discontinuation proposal; A drug storage facility that has fenfluramine or a pharmaceutically acceptable salt thereof stored in it; Cua The central controller of the system is programmed to monitor the 0:08 drug stock in the drug storage facility and is also programmed to control the dispatch of fenfluramine or a pharmaceutically acceptable salt from it from the drug storage facility drug “storage facility where the central controller is programmed to accept prescription-related dose-related information; the size; coll system » concentration and period of time required for use by the patient of fenfluramine or a pharmaceutically acceptable salt thereof; 0 where the central controller coordinates the following tests for the patient; Cus The central controller is programmed to describe the data format of the test results for each patient; Data format aligned with test data fields for each patient; Cus Lady The central controller is programmed to record test results for each patient over time; And to generate a chart showing a tendency for each patient. — 0 4 — and H 3 form a i 0 — 1 4 — tf 1 c oe | # 8 # z ab a y it 1 y form m 0 42- V+ except Ve YA A 1 BEE Bart | 3 = Bll Bl lw 858 z = , m ss nog hra b vo [A SL from A pas EPR Yee" "p 10 Aa - A py Tk Ye RAN = ' \Y Y shape p iii pour BRO m and | E ' : b l £4 yd ; P date form p — 4 4 — ( 087 or JD CI name a a (CE) \ 144 a : > “and \ m a 2 a b ab form 0 as d > a . , “For?” M Cae wt 1 0" > om — Jo Denne Fig. 1 Sued Authority for Intellectual Property RE .¥ + \ A 0 § 8 Ss o + < M SNE A J > E K J TE I UN BE Ca a a a ww Gaith > Ld Ed H Ed - 2 Ld, provided that the annual financial consideration is paid for the patent and that it is not null and void due to its violation of any of the provisions of the patent system, layout designs of integrated circuits, plant varieties and industrial designs, or its implementing regulations. 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